Senior Manager, Regulatory Affairs

Senior Manager, Regulatory Strategy to lead U.S. and global regulatory strategy for innovative neuroscience therapies.
Key Responsibilities
Develop and execute regulatory planning across the product lifecycle, from early development through post-approval.
Ensure compliance with applicable FDA and ICH requirements and alignment with corporate objectives.
Guide regulatory submissions including INDs, NDAs, and sNDAs.
Lead and manage interactions with regulatory agencies.
Assess regulatory risk and provide strategic guidance to influence portfolio decisions.
Partner cross-functionally to support patient-focused development goals.
Qualifications & Skills
Strong expertise in regulatory strategy, planning, and lifecycle compliance.
Proven ability to lead regulatory submissions and agency engagement.
Advanced risk assessment and decision-influencing skills.
Excellent cross-functional collaboration and communication.
Deep understanding of FDA/ICH expectations for innovative therapies.